MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX EMBOLIZATION DEVICE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-450-18

Device Problems Break (1069); Activation Failure (3270)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/19/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not received.Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that during the deploy of the ped2-450-18 in a straight segment, the distal end did not open well, therefore the device was attempted to be resheath, but the pipeline got stuck in the catheter and it was not possible to deploy it anymore.A continuous flush was used.Attempts to release the load were made but did not resolve the event.There was no damage to the pushwire or the catheter.The device was resheathed less than 2 times and less than 50 % was deployed when it failed to open at the distal tip.The device was removed with the catheter.The devices were prepared and used per the instructions for use.No patient injury occurred.New devices were used to treat the patient.This event occurred during the treatment of an unruptured, fusiform aneurysm.The vessel tortuosity was normal.

Manufacturer Narrative

Device evaluation h3: device evaluated by manufacturer- additional information h6: codes updated as received, the pipeline flex deliver system was found stuck within the medtronic catheter hub.The proximal end of pipeline pushwire was found extending from the catheter hub and the distal end of the pipeline flex extending.The pipeline flex delivery system was then removed from the phenom catheter.The pipeline flex delivery system was found to be separated at the distal end of the hypotube.The distal portion of the pipeline flex delivery system was found to be missing (proximal pad restraint, re-sheathing pad, re-sheathing marker, dps sleeves, braid and tip coil).The pipeline flex pushwire was found to be bent at multiple locations from proximal end.The broken end of the hypotube was sent out for sem (scanning electron micrographic) analysis.Per the sem analysis report, most of the fracture surfaces exhibit corrosion damage that obscured the original fracture features.Only a small area exhibits dimple features consistent with the ductile overload failure mechanism.However, no definitive conclusions can be provided.Based on the investigation conducted, use condition such as excessive force and patient vessel tortuosity can contribute to the event.Separation can occur if excessive force is used exceeding the tensile strength of the material.From the damages seen on the pipeline delivery system distal segment (missing) and hypotube (broken); it appears there was high force used.It is likely these damages occurred when the customer attempted to advance the pipeline flex through the catheter against resistance.However, the cause of the event could not be determined.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that during the deploy of the ped2-450-18 in a straight segment, the distal end did not open fine, therefore the device was attempted to be resheath, but the ped got stuck in the phenom27 and it was not possible to deploy it anymore.A continuous flush was used.Attempts to release the load were made but did not resolve the event.There was no damage to the pushwire or the catheter.The device was resheathed less than 2 times and less than 50 % was deployed when it failed to open at the distal tip.The device was removed with the catheter.The devices were prepared and used per the instructions for use.No patient injury occurred.New devices were used to treat the patient.This event occurred during the treatment of an unruptured, fusiform aneurysm.The vessel tortuosity was normal.

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9169161
• MDR Text Key: 194801376
• Report Number: 2029214-2019-01002
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2022
• Device Model Number: PED-450-18
• Device Lot Number: A847562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Date Manufacturer Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1